MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Unstable (1667); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: wagner sl revision hip stem, uncemented, 15/190, taper 12/14; catalog#: 01.00101.915; lot#: 3080465h21.Adler ortho head 36 mm; catalog#: 0813603; lot#: t36471ab.Adler ortho insert 54/56x36mm 3-b; catalog#: 0753352; lot#: t32159aa.Adler ortho screw 6.5 mm; catalog#: 0601030; lot#: t17518aa.Adler ortho screw 6.5 mm; catalog#: 0601030; lot#: t25940aa.Report source ¿ foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00313.

Event Description

It was reported that: the patient underwent a revision surgery approximately 1 month after the implantation due to periprosthetic instability and bone fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a3, a4, b4, b5, b7, g3, g6, h2, h10.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Event Description

Further information was received which reported that the patient experienced a left hip dislocation immediately after surgery.Revision surgery was performed approximately 1 month postop.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.Further information was received which reported that the patient was revised approximately 1 month postop due to dislocation.A pre-revision radiograph was provided and reviewed by a health care professional.The femoral component is dislocated superolaterally with respect to the acetabular cup.The acetabular cup demonstrates increased lateral inclination, a finding which can predispose to dislocation.Hardware appears intact.No periprosthetic lucencies.Bones appear intact without fracture or osteopenia.No signs of loosening, wear, radiolucency, or contributing factors.This corrected information does not change the outcome of the investigation previously reported.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation confirmed with increased lateral inclination noted as a contributing factor.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14539625
• MDR Text Key: 292963343
• Report Number: 0009613350-2022-00314
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430389
• UDI-Public: (01)00889024430389(17)310131(10)3059358
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-04
• Device Lot Number: 3059358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 72 KG